ADM Biopolis and Hospital de Sagunto, in Spain, have launched a clinical trial into the effects of administering a food supplement containing three of ADM’s live probiotic strains on COVID-19 patients. The trial began at the end of March and aims to promote gut microbiome balance to help improve health functions related to outcomes for COVID-19 patients in high-risk groups. Probiotics’ potential in tackling the novel coronavirus is increasingly brought to the fore and many players in the space are exploring this opportunity.
Gasteel Plus is a live microbial probiotic-based food supplement marketed by Laboratorios Heel España and was used in this interventional trial, as well as being formulated using ADM probiotic strains. The product has been administered to patients with COVID-19 symptoms, as well as to healthcare personnel at the hospital who fall into high-risk groups (the over 60s or those with chronic diseases) to strengthen their gut microbiota.
The three ADM probiotic strains contained in Gasteel Plus, namely Bifidobacterium longum CECT7347, Bifidobacterium animalis subsp. lactis CECT9950 and Lactobacillus rhamnosus CNCM-I4036, as well as essential nutrients vitamin D, selenium and zinc, have been shown in pre-clinical studies to exert anti-inflammatory, antioxidant and other immune-supporting effects.
“The strains used in the trial were chosen for their strong effect on the immune system as well as their anti-inflammatory properties. In addition, the two bifidobacterial strains were considered due to the fact that this microbial group is often lost in the gut microbiome of elderly people,” Daniel Ramón Vidal, Vice President, R&D Health & Wellness at ADM, tells.
“Like any nutritional supplement, the role of this product is, on the one hand, to prevent and, on the other, to complement the pharmacological treatment that patients receive. It is important to point out that we are analyzing the effect of a nutritional supplement; this is not a drug. That said, the preliminary data we have is very encouraging,” Vidal explains.
He goes on to explain that the daily dose of the three probiotics is one billion bacteria. Success is being measured by analyzing different variables, such as viral load, days of ICU stay, gastrointestinal symptoms and gut microbiome composition, along with blood markers of inflammation and immune system function.
“Only adults with informed consent and a positive PCR test for COVID-19 are participating in the study. There are no selection criteria based on sex or nationality,” Vidal adds.
In the same “probiotic” arena, Biosearch Life launched a clinical trial examining the effect of its Hereditum Immunactiv K8 product on COVID-19, while companies such as Probi and Lehvoss Nutrition, note a recent boost to their immunity-related probiotic products. Notably, last week Lallemand announced it is partnering with Canadian companies Biotechnologies Ulysse and Bio-K Plus to develop a vaccine against COVID-19. The vaccine could contain live bacteria and yeast that have the same properties as the virus, but without the contagious load of COVID-19.
Gut microbiome and COVID-19 link
On March 18, Dr. Xavier Cortés, gastroenterologist at Hospital de Sagunto, communicated with medical staff in China who had observed that many COVID-19 patients had exhibited abnormal changes in their gut microbiome. The reports indicated that a significant percentage of infected people experienced gastrointestinal problems in the early stages of the illness, similar to the trend he was observing in Spain.
This is particularly prevalent in elderly patients, who tend to have lower levels of beneficial bifidobacterial content in their gut microbiome, Dr. Cortés notes. Following his assessment, a decision was made that an interventional trial should be conducted to evaluate the effects of providing standard medication to elderly COVID-19 patients, along with a live microbial supplement to help support gut health and immune function.
Dr. Cortés contacted ADM’s scientific team for expert advice on the most potentially suitable live microbial strains to use during the trial and to invite the team to collaborate with Hospital de Sagunto in the design of the clinical trial.
“Thanks to the common efforts of three teams from the Hospital de Sagunto, Heel Laboratories and ADM Biopolis, we were able to start the trial at the end of March and we are discovering innovative solutions to challenging health and wellness concerns,” says Francisco Climent, ADM’s Health & Wellness Managing Director, EMEAI.
“More than 75 patients admitted to the hospital with COVID-19 have already been enrolled in the trial, and are giving regular blood, stool, urine and nasopharyngeal exudate samples to measure changes in immune parameters and other factors such as viral load,” notes Dr. Cortés. “Using these indicators, we will assess the efficacy of Gasteel Plus as an adjunct solution to support the health of the elderly population, who are especially vulnerable to this viral infection.”
In the coming weeks, ADM aims to expand the reach of this study to 100 patients, while simultaneously exploring the potential beneficial effects of additional ingredients, such as botanical extracts, oils and fibers in separate pre-clinical studies.
“Through this research, we hope to create more unique blends of our health and wellness ingredients that may help support the health of those for whom COVID-19 poses the greatest threat,” Climent concludes.